Billerica, MA Corporate HeadquartersPosition Summary:  Millipore Corporation strives to provide manufacturing bioprocess solutions to the biotech industry.

 A Millipore solution is a unique, comprehensive, and validated combination of products, services, and applications expertise for API and drug product manufacturing.

 The Senior QE would be responsible for providing quality assurance (specifically design assurance and quality by design, QbD) support for the development of new Millipore products and solutions pertaining to monoclonal antibody processing, cell culture/fermentation/harvesting, vaccine processing, purification, filtration, disposable processing, PAT This position reports to the Manager of Quality Engineering (BioProcess).

  Primary Responsibilities: Provide expert design assurance guidance and support for Millipore product, program, and solution development projects.

 Responsibilities to include: Quality by DesignDesign controlProduct and process validationcGMPRisk management Interface and coordinate activities with other quality functions including manufacturing site quality, quality systems, regulatory affairs, external quality groups, etcInterface with and leverage the entire matrix organization at Millipore in order to best achieve organizational goals.

Lead and support continuous improvement activities.

Education & Experience Requirements: 7-10+ years progressive, seasoned design assurance engineering within the pharmaceutical or biotech industriesExtensive validation experience within the pharmaceutical or biotech industriesMinimum - bachelors degree in related technical area (engineering, chemistry, microbiology, etc)Knowledge of domestic and international quality and regulatory requirements (ICH and CFR), including current industry interpretation.

 Hands on experience in the application of quality system standards Experienced at working in cross-functional international teams.

Other necessary expertise: Sterile processingContamination controlQuality control and testingFailure analysis and problem solvingContinuous improvementDevelopment of solutions to complex problemsWorking predominantly without direction, exercising considerable latitude in determining objectives and approachesCompetencies Required: High level of emotional intelligenceProject leadership Certified Quality EngineerSix Sigma CertificationApplied/industrial statisticsProject managementMust be able to multi-task and prioritize activitiesTechnical, scientific backgroundStrong written and verbal communication skills (internal/external)Relationship builder, cross-functional partnershipResiliency, flexibilityBroad global perspective cross cultural awareness and sensitivityStrong organizational skillsWillingness and ability to travel internationally to Millipore, vendor, partner, and customer locations  Sterile processingContamination controlQuality control and testingFailure analysis and problem solvingContinuous improvementDevelopment of solutions to complex problemsWorking predominantly without direction, exercising considerable latitude in determining objectives and approachesCompetencies Required: High level of emotional intelligenceProject leadership Certified Quality EngineerSix Sigma CertificationApplied/industrial statisticsProject managementMust be able to multi-task and prioritize activitiesTechnical, scientific backgroundStrong written and verbal communication skills (internal/external)Relationship builder, cross-functional partnershipResiliency, flexibilityBroad global perspective cross cultural awareness and sensitivityStrong organizational skillsWillingness and ability to travel internationally to Millipore, vendor, partner, and customer locations

« Apply for Design Assurance Engineer Job in Billerica 01821, Massachusetts US